MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-02-12 for 1.5T LINX, 17 BEADS LXMC17 manufactured by Torax Medical, Inc..
[179310821]
Pc (b)(4). Date sent: 02/12/2020. The dhr for lot 25261 was reviewed. No defects, ncrs, or reworks related to the product complaint were found.
Patient Sequence No: 1, Text Type: N, H10
[179310822]
It was reported that the patient had foam pooling in her throat with some solids occasionally. Resolves quickly. Subject had linx implant (b)(6) 2020. Our subject was admitted to the hospital last night. She is having vomiting. She is in observation and had basw which all looks normal. She is drinking normally and most likely will be d/c tomorrow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008766073-2020-00023 |
| MDR Report Key | 9703205 |
| Report Source | STUDY |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 4188 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN |
| Manufacturer Phone | 6107428552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.5T LINX, 17 BEADS |
| Generic Name | ANTI-REFLUX IMPLANT |
| Product Code | LEI |
| Date Received | 2020-02-12 |
| Model Number | LXMC17 |
| Catalog Number | LXMC17 |
| Lot Number | 25261 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAX MEDICAL, INC. |
| Manufacturer Address | 4188 LEXINGTON AVENUE NORTH SHOREVIEW MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-12 |